Kornimate/medical-research-clean huggingface dataset:
influence of central nervous insulin action on insulin sensitivity of peripheral organs in lean versus overweight humans

Conditions: Insulin Resistance

Summary: research in animals and first experiments in humans indicate that insulin action in the brain regulates peripheral insulin sensitivity. one major organ might be the liver. previous studies in humans showed that the human brain is an insulin sensitive organ in lean but not in overweight/obese persons. therefore, this study will include lean versus overweight/obese persons. in this study, insulin action will be introduced by intranasal insulin administration in lean and overweight humans. as a control, placebo spray will be administered. to mimick the known spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin will be administered over 15 minutes following placebo spray application. peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp and glucose uptake and endogenous glucose production will be assessed by tracer dilution technique. autonomous nervous system activity will be addressed by heart rate variability. involved brain areas will be addressed by fmri before and after nasal insulin application.


Eligibility criteria:
inclusion criteria: * male volunteers (lean or overweight/obese) * hba1c \<6.0% * age between 18 and 40 years * healthy as assessed by physician * understanding the explanations about the study and instructions exclusion criteria: * non-removable metal parts in or on the body * persons with reduced temperature sensation and / or increased sensitivity to warming of the body * cardiovascular disease can not be excluded, such as evident coronary heart disease, congestive heart failure nyha greater than 2, history of coronary artery disease * history of stroke * persons with a hearing disorder or increased sensitivity to loud noises * people with claustrophobia * subjects in which less than 3 months have passed since surgery * simultaneous participation in other studies * acute disease or infection within the last 4 weeks * neurological and psychiatric disorders * subjects with hemoglobin hb \<13g / dl * heparin-induced thrombocytopenia people with a (hit) in prehistory * allergies to any of the used solutions/devices

Keywords: intranasal insulin
iron administration via colonic tet combined with wmt for id

Conditions: Iron Deficiency Anemia in Childbirth

Summary: the colon can absorb iron.we propose an integrated approach utilizing colonic transendoscopic enteral tubing to deliver iron in different valence states, coupled with washed microbiota transplantation . this clinical trial aims to assess the feasibility, safety, and efficacy of this approach for the treatment of iron deficiency.

at least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. data of demographic characteristics, reticulocyte hemoglobin, ferritin and clinical outcomes will be collected. after treatment, they will enter the follow-up period for safety and efficacy evaluation.

Eligibility criteria:
inclusion criteria: 1. ferritin ≤30 μg/l; 2. feasible colonic tet placement (cephalic end in the ileocecal region); 3. completion of 3 wmt sessions. exclusion criteria: 1. the patient has other co-morbidities that can lead to iron deficiency, such as acute gastrointestinal haemorrhage and menorrhagia.etc. 2. people who are allergic to iron or taking oral medications that interfere with iron absorption. 3. patients with heart, brain, lung, liver, kidney and other serious diseases; 4. patients do not cooperate to complete the clinical trial process;

Keywords: iron transendoscopic enteral tubing washed microbiota transplantation iron deficiency
conservative treatment for ventral hernia

Conditions: Ventral Hernia

Summary: the aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation.


Eligibility criteria:
inclusion criteria: all patients (older than 18 years) referred to the surgical department of køge university hospital from 2009 - 2014 with the diagnosis ventral hernia
expanded access to omaveloxolone for melanoma for patients previously enrolled in 408-c-1401

Conditions: Melanoma

Summary: this is an expanded access program for eligible participants and is designed to provide access to omaveloxolone for the treatment of unresectable or metastatic melanoma to patients who previously participated in the 408-c-1401 (reveal) study. to be considered for expanded access, a principal investigator from the reveal trial should submit a request to reata pharmaceuticals on behalf of the individual patient.

study sponsor, originally reata pharmaceuticals, inc., is now reata pharmaceuticals, inc., a wholly owned subsidiary of biogen.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: melanoma omaveloxolone expanded access
effects of exogenous ketone ester supplementation on 3-hydroxybutyrate concentrations in human cerebrospinal fluid

Conditions: Ketosis

Summary: it is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies. ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-ohb). 3-ohb is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (mcts) across the blood-brain barrier. to our knowledge, no studies in human adults exist that concurrently measure 3-ohb concentrations in blood and cerebrospinal fluid (csf) after ingestion or infusion of exogenous ketone supplementation, necessitating further study. aims: * the 3-ohb csf/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint * the window of effect: ketone supplementation 1 h or 2 h before csf sampling * if concentration measurements by point-of-care testing are non-inferior to mass spectrometry * if acute 3-ohb ingestion increases plasma brain-derived neurotrophic factor (bdnf) levels


Eligibility criteria:
inclusion criteria: * all sexes * referred to undergo an elective lumbar puncture procedure in the outpatient clinic at department of neurology, aarhus university hospital. * age 18-80 years * written and oral consent exclusion criteria: * referred to the clinic suspecting severe neuroinflammation * special diet habits, including ketogenic diet, fasting, intermittent fasting etc. * daily use of insulin or other medication affecting blood glucose and/or glucose metabolism * not able to speak or understand danish and/or give written and oral consent

Keywords: cerebrospinal fluid brain-derived neurotrophic factor point-of-care testing ketone bodies ketone body adminstration
use of chamomilla recutita in phlebitis

Conditions: Phlebitis

Summary: to verify the efficacy of topical applications of chamomilla recutita infusion for phlebitis treatment, before dose response curve study and pilot study.

the hypothesis adopted was that patients with phlebitis due to peripheral intravenous infusion in anti-neoplasm chemotherapy, treated with a compress of chamomilla recutita infusion for 20 minutes three times per day, would present a shorter phlebitis regression time in comparison with patients treated with a lukewarm water compress.

Eligibility criteria:
inclusion criteria: * subjects with cancer who had infusion phlebitis during the administration of intravenous chemotherapy peripheral under hospitalization. exclusion criteria: * report made by the subject of study, prior hypersensitivity reaction or presentation during the research, adverse reaction to chamomile or any plant of the family asteraceae ou compositae: margarida (aster tripolium), crisântemo (chrysanthemum leucanthemum), artemísia or isopo santo (artemísia vulgaris), carpineira or ambrósia americana (ambrosia artemisiifolia) and senécio (senecio jacobaea l.); * prescription during the process of data collection, some kind of anti-inflammatory with systemic or topical activity where it was located phlebitis, and, upon the occurrence of bacterial phlebitis, had been prescribed topical or systemic antibiotic therapy; * refusal of the subject to participate in the study, regardless of the time.

Keywords: phlebitis chamomilla recutita catheterization peripheral
safety and efficacy of an antibody to ccr5 in individuals with hiv who are not currently on antiretroviral therapy

Conditions: HIV Infections

Summary: this is a phase 1, randomized, placebo-controlled, dose-escalation study of ccr5mab004 in hiv-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. subjects will be randomly assigned to receive a single intravenous (iv) infusion of one of four dose levels of ccr5mab004 or matching placebo. a minimum of 10 subjects will be randomized to each cohort at a ratio of 4:1 (active:placebo). a minimum of 40 and maximum of 60 subjects will be enrolled. this study will be conducted at up to 10 sites in the united states. subjects in each cohort will be followed for 56 days after study agent administration. the safety, tolerability, and immunogenicity of ccr5mab004 will be evaluated based on physical examination, adverse event (ae) reporting, and clinical laboratory tests. blood will be collected at specified times for the determination of ccr5mab004 serum concentrations, hiv-1 rna levels, and cd4+ and cd8+ cell counts. if cd4+ cell counts are less than 200 during the study period, the subject should be offered standard-of-care per hiv treatment guidelines that may include the initiation of appropriate anti-retroviral therapy (avr). ccr5mab004 pharmacokinetic (pk) and pharmacodynamics (pd) will be measured over the 56-day study period. anti-ccr5mab004 antibody titers will be assessed prior to dosing on day 0 and on day 28 and day 56.


Eligibility criteria:
inclusion criteria: * hiv-1 infection confirmed by enzyme immunoassay (eia) and western blot. * age 18 to 64 years. * hiv-1 rna \> 5000 copies/ml. * cd4+ t cell count \> 250 cells/ul. * treatment naïve, or off antiretroviral treatment for at least 30 days prior to screening and 60 days prior to day 0 * ccr5 tropism confirmed by r5 phenosense assays. exclusion criteria: * cxcr4 tropic or dual tropic virus at screening. * laboratory values of grade 3 or greater according to the modified division of microbiology and infectious diseases (dmid) adult toxicity tables. * history of category c aids-defining illness according to the 1993 centers for disease control and prevention (cdc) aids surveillance definition. * history of any medical disease or condition that makes the subject (in the opinion of the investigator) unsuitable for the study. * malignancy within the past 5 years (except for basal carcinomas of the skin and in situ cancers of the cervix). * females who are pregnant or breastfeeding, or who plan to become pregnant during the study. * subjects whose dosage or number of prescription medications has changed within 30 days prior to screening * positive for hepatitis b surface antigen (hbsag) or antibody to hepatitis c virus (hcv). * positive alcohol or drug screen

Keywords: hiv treatment naive
soleus h-reflex in different sitting postures

Conditions: Compression of Spinal Nerve Root; Spinal Disorder; Low Back Pain

Summary: the purpose of this study was to examine the effect of prolonged sitting duration and three different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve root function by measuring the soleus (sol) h-reflex amplitude. in addition, the pressure under the ischial tuberosities during the three sitting postures were assessed and correlated with the sol h-reflex amplitude.

participants were assigned to two groups (prolonged sitting group and controls) based on their daily sitting duration with 15 participants in each group. the outcome measures were recorded during erect, slumped and slouched sitting postures. the differences between the two groups and the three sitting postures in the outcome measures were examined for statistical significance.

Eligibility criteria:
inclusion criteria: * able to read, speak, and understand english exclusion criteria: 1. current complaint of low back pain. 2. current injury to the ankle and/or foot. 3. limited ankle movement. 4. leg length discrepancy. 5. scoliosis. 6. history of: * back surgery. * calf muscle injury/surgery. * radicular symptoms. * peripheral neuropathy. * upper motor neuron lesion. * systemic and metabolic diseases. * cancer. 7. pregnant at the time of the study. 8. use of pain medications at the time of the study.

Keywords: lumbosacral spine nerve roots sitting h-reflex
regional anesthesia and partial mastectomy

Conditions: Breast Neoplasm

Summary: pectoralis nerves plane block (pecs) first described by blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. the combination of low complication risk and easiness in mastering of pecs block has made it an interesting alternative to thoracic epidural anesthesia (teda) and paravertebral blockade (pvb) for pain treatment after breast surgery. several studies showed good results when pecs was compared to pvb. pecs blockade however is a procedure requiring some resources in the operating room. an alternative approach is to inject local anesthetics (la) in the operation field by the surgeon. the hypothesis' tested in this study is primarily: that pecs blockade is superior to la being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (ponv) and length of stay in the post anesthesia care unit (pacu).


Eligibility criteria:
inclusion criteria: * women scheduled for partial mastectomy (lumpectomy). exclusion criteria: * scheduled cryosection * axillary node dissection * re-resection * age under 18 or unable to give an informed concent * chronic pain history * allergy to local anesthetics * history of active drug addiction * pregnancy

Keywords: segmental mastectomy, analgesia regional anesthesia breast surgery
does less trendelenburg make a difference in robotic assisted gynecological procedures?

Conditions: Benign Female Reproductive System Neoplasm

Summary: patient/population: women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at lutheran general hospital. intervention: decreasing the angle of trendelenburg for the procedure control: steep trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees. outcome: outcomes will include the mean angle of trendelenburg in the experimental arm and the difference in trendelenburg between the two arms. additional outcomes included will be end tidal carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial carbon dioxide. secondary outcomes will include operative time, blood loss and conversion to laparotomy.

for any patient undergoing robotic-assisted benign laparoscopic procedures at lutheran general hospital were eligible to participate. each subject was randomized to steep or a decreased angle of trendelenburg. while under anesthesia an arterial line would be placed to monitor vital signs. at specific time points throughout surgery, all vital signs were measured including end tidal co2, peak airway pressure, mean arterial pressure, heart rate and arterial co2 as well as operative time, blood loss and conversion to laparotomy. the arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.

Eligibility criteria:
inclusion criteria: * all women at lutheran general hospital undergoing robotic-assisted benign gynecologic procedures and who agree to participate in the study. * women who are 18 years or older on the day of surgery. * patients with any co-morbidity or prior surgery, as long as they are cleared by their surgeon and anesthesia to undergo robotic-assisted surgery. exclusion criteria: * pregnant women * anyone who is less than 18 years old on the day of surgery. * anyone who does not have the capacity to make independent medical decisions.

Keywords: trendelenburg position robotic assisted gynecologic procedures benign gynecologic conditions
economic and functional impact of peri-operative bracing for primary total knee arthroplasty (tka)

Conditions: Arthropathy of Knee

Summary: while bracing has been shown to be beneficial for patients with osteoarthritis (oa) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (tka) surgery needs to be examined. therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in oa patients can also increase strength and function in patients after tka.


Eligibility criteria:
inclusion criteria: age: 50 years or older exclusion criteria: * bmi \> 40 * radiographic deformity of greater than 10 degrees
efficacy of closed-loop insulin therapy in prepubertal child in free-life

Conditions: Type 1 Diabetes Mellitus in Prepubertal Children

Summary: the study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. after 3 weeks of outpatient use of study pump (1 week) and study pump+cgm (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (ap) mode. following randomization (1:1), patient will be allocated to '24-hour' use of ap or 'dinner and overnight ap mode/day time pump and cgm use' for the next 18-week period. at 18-week visit, a study extension for a further 18-week period will be initiated. ap mode that will be prescribed to all patients will depend from an independent dsmb decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. visits will occur at week 27 (safety follow-up) and 36 (final visit).

the study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. after 3 weeks of outpatient use of study pump (1 week) and study pump+cgm (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (ap) mode. following randomization (1:1), patient will be allocated to '24-hour' use of ap or 'dinner and overnight ap mode/day time pump and cgm use' for the next 18-week period. a hotline phone number will be given to the patient and parents so that they can contact the study staff as needed. a logbook will be provided to collect details about hypoglycemic and hyperglycemic episodes, physical activity and noticeable events. phone calls will be scheduled between investigator and patient+parents 48 hours, 1 week and 2 weeks after ap mode initiation. potential misbehaviors will be corrected and all questions answered. if needed, ap parameters may be revised and reconfigured. hospital visits will be scheduled 6, 12 and 18 weeks after ap mode initiation for the same purposes, plus hba1c measurement at week 12 and 18. at 18-week visit, a study extension for a further 18-week period will be initiated. ap mode that will be prescribed to all patients will depend from an independent dsmb decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. visits will occur at week 27 (safety follow-up) and 36 (final visit).

Eligibility criteria:
inclusion criteria: * treatment of diabetes by insulin pump since \> 6 months * hba1c level \< 10% exclusion criteria: * unwillingness of one parent or the legally responsible party to participate in insulin treatment * any associated chronic disease or therapy (except insulin) affecting glucose metabolism

Keywords: type 1 diabetes prepubertal children closed-loop insulin infusion
a multicentre, non-blinded study exploring self-administration of chemotherapy in the home environment

Conditions: Myeloma; Myeloma Multiple

Summary: this study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. all tests and assessments are based on standard of care procedures.

chemotherapy for malignancies is predominantly prescribed and delivered in a tertiary hospital and/or cancer centre setting. however, with modern chemotherapy, with a reduced side effect profile, this paradigm should be challenged. indeed, the use of methotrexate and other biologics (a form of chemotherapy) in the rheumatologic setting is commonly delivered effectively and safely in the community. taken together, a hospital-based model of chemotherapy delivery may not be warranted in all circumstances. moreover, the use of this current model invariably discounts the time commitments, needs of patients and caregivers, as well as while not addressing the emerging concerns regarding system capacity, efficiency and effectiveness of safe chemotherapy delivery.

Eligibility criteria:
inclusion criteria: * patients are aged 18 years old or older with a diagnosis of symptomatic myeloma, * stable clinical status as deemed by responsible investigator, * personally (or caregiver) willing and deemed capable to self-administer with teaching, * previously received more than 4 injections of bortezomib within the hospital and/or cancer centre environment, * signed informed consent. exclusion criteria: * currently participating in clinical trials that includes the use of bortezomib, * history of allergic reactions to bortezomib, * history of bleeding attributable to bortezomib, * history of greater than or equal to grade 3 side effects attributable to bortezomib, * clinically deemed unlikely to be compliant with therapy by responsible investigator, * life expectancy anticipated to be less than 6 months, * deemed geographically inaccessible to receive care.
bimanual motor skill learning through robotics in chronic cerebellar stroke survivors and healthy individuals

Conditions: Chronic Cerebellar Stroke; Healthy Individuals (Controls)

Summary: to test capacity of chronic cerebellar stroke patients and healthy individuals to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot reaplan® (bimanual version).

over 3 consecutive days, healthy individuals and chronic cerebellar stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot reaplan®. they will practice several tasks on the robot reaplan® (bimanual version), requiring either movements with the affected arm (unimanual tasks) or complex, coordinated movements with both arms (bimanual tasks). in addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...). hand/digits motor function will be also evaluated with the kinetic device dextrain®.

Eligibility criteria:
stroke patients: inclusion criteria: * having a chronic cerebellar stroke (\>6 months) * aged 18-90 years * with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging exclusion criteria: * difficulty in understanding or executing commands * drug/alcohol abuse * severe aphasia / cognitive deficits interfering with study * inability to voluntarily move the affected arm (i.e. complete paralysis of the arm) * multiple strokes / dementia / psychiatric condition healthy individuals: inclusion criteria: * 18-90 years exclusion criteria: * neurological conditions interfering with the study * drug/alcohol abuse * pyschiatric condition

Keywords: stroke cerebellar disorders cerebrovascular disorders brain diseases central nervous system diseases nervous system diseases vascular diseases cardiovascular diseases cerebellar stroke cerebellar hemorrhage cerebellar infarction